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A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis : childhood outcomes at 5 years
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Marlow, Neil, Morris, Timothy, Brocklehurst, Peter, Carr, Robert, Cowan, Frances, Patel, Nishma, Petrou, Stavros, Redshaw, Margaret, Modi, Neena and Doré, Caroline J (2015) A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis : childhood outcomes at 5 years. Archives of Disease in Childhood - Fetal and Neonatal Edition, 100 (4). F320-F326. doi:10.1136/archdischild-2014-307410 ISSN 1359-2998.
An open access version can be found in:
Official URL: http://dx.doi.org/10.1136/archdischild-2014-307410
Abstract
Objective We performed a randomised trial in very preterm, small for gestational age (SGA) babies to determine if prophylaxis with granulocyte macrophage colony stimulating factor (GM-CSF) improves outcomes (the PROGRAMS trial). GM-CSF was associated with improved neonatal neutrophil counts, but no change in other neonatal or 2-year outcomes. As subtle benefits in outcome may not be ascertainable until school age we performed an outcome study at 5 years.
Patients and methods 280 babies born at 31 weeks of gestation or less and SGA were entered into the trial. Outcomes were assessed at 5 years to determine neurodevelopmental and general health status and educational attainment.
Results We found no significant differences in cognitive, general health or educational outcomes between 83 of 106 (78%) surviving children in the GM-CSF arm compared with 81 of 110 (74%) in the control arm. Mean mental processing composite (equivalent to IQ) at 5 years were 94 (SD 16) compared with 95 (SD 15), respectively (difference in means −1 (95%CI −6 to 4), and similar proportions were in receipt of special educational needs support (41% vs 35%; risk ratio 1.2 (95% CI 0.8 to 1.9)). Performance on Kaufmann-ABC subscales and components of NEPSY were similar. The suggestion of worse respiratory outcomes in the GM-CSF group at 2 years was replicated at 5 years.
Conclusions The administration of GM-CSF to very preterm SGA babies is not associated with improved or more adverse neurodevelopmental, general health or educational outcomes at 5 years.
Item Type: | Journal Article | ||||||||
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Journal or Publication Title: | Archives of Disease in Childhood - Fetal and Neonatal Edition | ||||||||
Publisher: | B M J Group | ||||||||
ISSN: | 1359-2998 | ||||||||
Official Date: | July 2015 | ||||||||
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Volume: | 100 | ||||||||
Number: | 4 | ||||||||
Page Range: | F320-F326 | ||||||||
DOI: | 10.1136/archdischild-2014-307410 | ||||||||
Status: | Peer Reviewed | ||||||||
Publication Status: | Published | ||||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||||
Open Access Version: |
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